Hybrid QA Operations Specialist – Quality & Compliance

Merck; Leinster; Hybrid; EUR 70,000 - 97,000; Full time

Benefits offered by this job

Hybrid work model

Employee wellness program

Job summary

Merck in Dundalk, Ireland, seeks a Senior Specialist in Quality Assurance Operations to provide independent quality oversight across Drug Substance and Drug Product manufacturing. You will partner with Manufacturing, Quality Control, Engineering, Technical Operations, Supply Chain, and Quality Systems to ensure compliance and operational excellence.

This high-visibility role supports commercial manufacturing, technology transfer, investigations, and continuous improvement activities while

Qualifications

• Bachelor's degree in a scientific or engineering field.
• Minimum of 5 years in a GMP-regulated environment (pharma/biotech/biologics).
• Deep knowledge of GMP, Quality Systems, deviations, CAPA, and change control.

Responsibilities

• Provide quality oversight for Drug Substance and Drug Product manufacturing.
• Review and approve GMP documentation, batch records, protocols, reports, and manufacturing records.
• Support batch disposition activities and quality decision-making processes.
• Lead and support investigations, deviations, corrective and preventive actions, change controls, and risk assessments.
• Partner with manufacturing and technical teams to support technology transfer, process validation, and commercial manufacturing activities.
• Drive inspection readiness and support internal audits and regulatory inspections.
• Monitor quality performance metrics, identify trends, and implement continuous improvement initiatives.
• Provide GMP guidance and quality expertise across manufacturing and support functions.
• Support site and global quality projects, change initiatives, and compliance programmes.
• Champion a culture of quality, compliance, accountability, and operational excellence.

Skills

GMP knowledge

Quality Systems

Investigations

Batch disposition

CAPA

Change control

Regulatory readiness

Cross-functional collaboration

Inspection readiness

Education

Bachelor's degree in Biotechnology, Microbiology, Pharmacy

Tools

Quality Management Systems (QMS)

Job description

Merck in Dundalk, Ireland, seeks a Senior Specialist in Quality Assurance Operations to provide independent quality oversight across Drug Substance and Drug Product manufacturing. You will partner with Manufacturing, Quality Control, Engineering, Technical Operations, Supply Chain, and Quality Systems to ensure compliance and operational excellence.

This high-visibility role supports commercial manufacturing, technology transfer, investigations, and continuous improvement activities while